The University of Colorado Cancer Center (UCCC) is the only NCI-designated Comprehensive Cancer Center in the Rocky Mountain region - an area with a population of approximately eight million people. Over the past four years, the NCI sponsored research portfolio has remained stable at about $40 million, excluding the Core grant. Outpatient visits and now clinically active faculty are growing, which we hope will translate into a marked increase in patient accruals to clinical trials. UCCC is a "matrix" center within the University of Colorado Denver (UCD) and has completed its move to its new campus at the old Fitzsimons Army base (Anschutz Medical Campus). Its major clinical care centers include the University of Colorado Hospital (UGH), Denver Veterans Administration Medical Center (DVAMC), Denver Health Medical Center (DHMC), and The Children's Hospital Denver (TCH). We also have a growing number of outreach clinics staffed directly by our faculty including Montrose Hospital in Montrose, Valley View Hospital in Glenwood Springs, and Vail Valley Medical Center in Edwards. Others are in development including at Alamosa. We have affiliates (CGOPs) including Memorial Hospital in Colorado Springs and Poudre Valley Medical Center in Fort Collins. Our U10- and UGOP- funded membership in the Southwest Oncology Group (SWOG) fulfills many of the goals of our Cancer Center by providing broad access to innovative phase II and III treatment and chemoprevention trials to the citizens of Colorado. This grant provides partial support for the needed monitoring and oversight to run clinical trials at the main institutions and outreach clinics and affiliates. Our faculty, in turn, have provided strong administrative and scientific leadership, particularly in the GU and Lung Committees and the Surgery, Pathology and Radiation Therapy modalities as documented by serving or chairing SWOG committees, serving as PIs for phase ll/lll SWOG group trials including PCPT and SELECT, conducting pilots to provide the basis for subsequent SWOG trials, and then accruing subjects. We expect significantly increased activity in the Breast and Gl committees during the next grant cycle. Clinical trials represent the state-of-the-art in cancer treatment and prevention and should be broadly available and offered to the citizens of Colorado. RELEVANCE: Clinical trials, especially phase III studies, drive progress and establish new standards of care (SOC) that must then be improved on. It is no accident that the majority of phase III oncology trials prove that the experimental arm is superior to the previous SOC, but progress is incremental. This grant provides essential resources to support these clinical trials to our Cancer Center and to multiple sites around the Rocky Mountain region. Access to clinical trials is crucial for excellence in health care. PRINCIPAL INVESTIGATOR: Dr. Elias is a Professor of Medicine and Associate Director for Clinical Sciences for the UCCC as well as the Medical Director of the Breast Cancer Clinical Program at the University of Colorado. He has been the PI for the UCCC SWOG U10 for the past 6 years. He is fully qualified for his position. PROTECTION OF HUMAN SUBJECTS (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE Enrolled subjects are generally 18 years of age or older. OVERALL RECOMMENDATION: This application is rated 33 and is recommended for six years of support.